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A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
Published on: August 9, 2022
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Stability studies of cefoselis sulfate in the solid state
Przemysław Zalewski1, Robert Skibiński2, Alicja Talaczyńska1
1Department of Pharmaceutical Chemistry, Poznan University of Medical Sciences, Grunwaldzka 6, 60-780 Poznań, Poland.
Journal of Pharmaceutical and Biomedical Analysis
|June 16, 2015
Summary
The stability of cefoselis sulfate was investigated under varying humidity and temperature. Degradation pathways were identified, revealing autocatalytic and first-order kinetics influenced by environmental conditions.
Area of Science:
- Pharmaceutical Chemistry
- Chemical Kinetics
- Analytical Chemistry
Background:
- Cefoselis sulfate is an important pharmaceutical agent.
- Understanding its degradation is crucial for drug stability and efficacy.
- Environmental factors significantly impact drug stability.
Purpose of the Study:
- To investigate the degradation of cefoselis sulfate.
- To identify degradation products and pathways.
- To determine the influence of temperature and relative humidity on cefoselis sulfate stability.
Main Methods:
- High-Performance Liquid Chromatography with Diode Array Detection (HPLC-DAD) was employed for degradation studies.
- A hybrid Electrospray Ionization-Quadrupole Time-of-Flight (ESI-Q-TOF) mass spectrometer was used for product identification.
- Kinetic analysis was performed to understand degradation rates.
Main Results:
- Two primary degradation products of cefoselis sulfate were identified.
- Degradation followed an autocatalytic first-order reaction at increased relative humidity (RH).
- In dry air, degradation followed a first-order reaction dependent on substrate concentration.
Conclusions:
- Temperature and RH significantly affect cefoselis sulfate stability.
- The identified degradation kinetics provide insights into solid-state stability.
- Calculated kinetic and thermodynamic parameters are essential for predicting shelf-life.
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